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Arovella Therapeutics Ltd (ALA)

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A Deep Dive profile provides ASX listed companies with an opportunity to tell their story in plain English.

Company Deep Dive

Arovella Therapeutics (ASX: ALA) is a biotechnology company focused on developing therapies to treat human diseases. Their two focus areas are oncology and conditions that impact the central nervous system.

Arovella's experienced leadership is invested in making a positive difference in helping patients live longer and healthier lives. Creating a brighter future for people is their driving force.

Its most advanced product is ZolpiMist, an oro-mucosal spray version of Ambien for the treatment of short-term insomnia, which is partnered in certain regions with Teva and STADA Pharmaceuticals Australia. ALA recently in-licensed an invariant natural killer T (iNKT) cell therapy platform that can be used in conjunction with chimeric antigen receptors to target blood cancers. There are a number of potential benefits of CAR-iNKT, including the prospect of being an allogeneic ‘off-the-shelf’ therapy, significantly simplifying the manufacture of the therapy and its delivery to patients. 

In December 2021, ALA in-licensed patent rights for a monoclonal antibody that targets a Dickkopf-1 (DKK1) peptide, which is expressed in the tumour cells of multiple myeloma and other types of cancer. ALA plans to combine the DKK1 targeting technology with the iNKT cell therapy platform (which is currently at the preclinical stage). ALA is targeting very large markets including insomnia (through ZolpiMist) and various cancers (through the CAR-iNKT programs and anagrelide).

 

Why invest In Arovella?

Arovella is the only ASX listed company working with an iNKT cell therapy platform

The only company worldwide with CAR technology targeting a DKK1 peptide

Arovella’s leadership group has deep experience in drug development, particularly cell therapies

World class partnerships where Arovella licenced its iNKT Cell Therapy Platform from Imperial College London and its DKK1 mAb/CAR from MD Anderson

Robust intellectual property with patent life for its CAR-iNKT cell manufacturing until 2038 and its DKK1 technology until 2039.

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People

Leadership Team

Paul Hopper

Chairman

An Australian bioentrepreneur, Paul has been behind numerous successful oncology biotechs, acquiring the rights to some of the most promising cancer therapies - his biggest success to date has been Viralytics - acquired by Merck in 2018 for $US394 million.

Dr Michael Baker

CEO & MD

Passionate about creating life changing medications for the betterment of humankind, Dr Baker’s careers spans academic research, drug development and venture investing. His primary focus is to get medications into the hands of patients that need them.

Dr Debora Barton

Non-Executive Director

Dedicating her career to the treatment of cancer, Dr Barton began her career as a clinical oncologist before moving into drug development in large pharmaceutical companies and more recently into biotechnology companies at the forefront of cancer treatment. Dr Barton also serves to enhance cancer awareness and advocacy through her roles at the Tigerlily Foundation, and the American Cancer Society.

David Simmonds

Non-Executive Director

With a decades-long career as senior audit partner with Ernst and Young, David brings a wealth of financial and audit experience to Arovella Therapeutics. He was involved with Ramsay Health Care Ltd, John Fairfax Holdings and Commonwealth Bank of Australia, and also audit partner for the Australian operations of the US technology companies Hewlett Packard, Sun Microsystems and Oracle.

Elizabeth Stoner

Non-Executive Director

Dr Stoner is a distinguished biopharma executive, who brings decades of international industry experience to her role, including senior roles in Clinical Development Operations at Merck Research Laboratories. Liz is an Executive Partner at MPM Capital, and she has held numerous leadership roles at MPM portfolio companies. Liz was previously an Assistant Professor of Paediatrics at Cornell University Medical College.

Management Team

Dr Sandhya Buchanan

VP Manufacturing and Quality

Dr Buchanan is dedicated to bringing our life-changing medicines to patients through pioneering science, commitment to excellence, and cross-functional teamwork. Her primary focus is leading and advancing the Chemistry, Manufacturing and Control (CMC) components of our allogeneic iNKT-cell therapy, including Development, Manufacturing, Quality and Quality Control Operations.

Dr Mini Bharathan

VP Development & Translational Medicine

Dr Mini Bharathan has spent her career in the field of immunology and developing innovative cell therapies to treat human disease. Mini has over 15 years of biotechnology industry experience leading preclinical and translational medicine research teams. Mini will drive the development of Arovella’s pipeline of iNKT cell therapies into and through clinical trials.

Dr Deborah Cooper

Development Manager

Having worked in the pharmaceutical industry for more than 25 years, Dr Cooper brings a wealth of drug development experience to Arovella Therapeutics. Dr Cooper’s experience covers many areas of drug development and including senior and executive level positions.

Uthayamalar Armugam ,PMP

Program Manager

A seasoned Program Manager in the pharmaceutical industry, having spent time at GSK, Pfizer, Hospira and Mayne Pharma. As a certified Project Management Professional and a lean six sigma green belt, Malar is well versed in managing complex projects.

Technology & Treatments

Treatment

CAR-iNKT

Chimeric Antigen Receptor (CAR) invariant Natural Killer T (iNKT) cell therapy – CAR-iNKT – has been developed for the treatment of cancer. iNKT cells naturally target cancer cells and by introducing a CAR, for cancers that produce CD1d and they are dual targeting having enhanced activity over conventional CAR-T cells.

  • “Off-the-shelf” potential where one source can treat multiple patients

  • CAR-iNKT cells work more efficiently than conventional cell therapies

  • Initial drug development focusing on hematological malignancies (blood cancers).

Pre-clinical studies have shown that CAR-iNKT cells can result in a spontaneous secondary remission without additional treatment.

Treatment

DKK1-CAR- iNKT

The DKK1 mAb was developed at MD Anderson and can be incorporated into a chimeric antigen receptor (CAR) . Arovella will combine the DKK1-CAR with its iNKT cell therapy platform and initially target multiple myeloma, where DKK1 is highly expressed.

  • DKK1 has recently emerged as a potential biomarker of cancer progression and prognosis for several types of malignancies.

  • DKK1-CAR- iNKT only kill cells that have the DKK1 peptide presented in an HLA-A2 complex on their surface.

 

Treatment

Anagrelide

Arovella is developing anagrelide as a first-in-class approach to the treatment of cancer, potentially applicable across a wide range of solid tumors. Newer cancer treatments involve immunotherapy which stimulates the patients’ own immune system thus offering a valuable new adjunctive therapy.

  • Anagrelide is currently used to reduce elevated platelets and lower the thrombotic risk in myeloproliferative diseases associated with high platelet counts.

  • Anagrelide has been approved to treat Essential Thrombocythemia in the US and the EU.

Anagrelide has been in clinical use for >20 years and has a demonstrated safety profile.

 

Treatmet

ZolpiMist

ZolpiMist® is a first-in-class, US-approved, cherry-flavored, fast-acting oral spray version of zolpidem tartrate (marketed under the brand name of Ambien® or Stilnox®), a non-benzodiazepine prescribed for the treatment of insomnia.

ZolpiMist advantages include reduced sleep latency, patient convenience, and ease of use as it is administered without the need for water.

STADA to commercialize SUDA’s TGA approved ZolpiMist in Australia (upfront payments and a double-digit royalty).

 

Technology

OroMist®

OroMist is oro-mucosal delivery technology that can deliver a broad range of drug classes through either the cheeks, gums, tongue or floor of the mouth. The technology is compatible with, and patents have been filed for use in either pump (air-activated) or aerosol (propellant-driven) spray systems, and can be provided in either multi-dose or unit containers based on the medical need and marketing requirements for each product.

As delivery of the drug becomes more efficient, then the benefits for the patient include:

  • Faster onset of action;

  • Lower amount of drug required;

  • Reduced side effects;

  • Increased patient compliance.

Key Milestones

Historic Milestones

Commenced CAR19 Plasmid and Vector Manufacturing
DKK1-peptide mAb Licence Agreement MD Anderson
Ministry of Health Approval for ZolpiMist
Arovella completes ZolpiMist Licence agreement with STADA Australia
Arovella acquired the licence for a novel iNKT cell Therapy from Imperial

Future Milestones

Developing the clinical plan for ALA-101(CAR19-iNKT)
To commence manufacturing of the lentiviral vector shortly
To develop clinical plan for ALA-104( DKK1- CAR- iNKT)

Investment

Merchant (Recent Placement)

Capital Raise

ALA SPP closed early and oversubscribed
|Feb 2022

The funds will be used to fund manufacturing of components for the CAR19- iNKT cell therapy, to perform preclinical studies for DKK1-CAR-iNKT, as well as for general working capital purposes.

Raised $2m
Offer Price -
Notes

Documents

March Quarterly Activities Report

28 Apr 2022 | Report
PDF (553 KB)

Half Yearly Report Ending Dec 2021

28 Feb 2022 | Report
PDF (741.5 KB)

Investor Presentation

01 Feb 2022 | Presentation
PDF (5071.7 KB)

December Quarterly Activties Report

31 Jan 2022 | Report
PDF (758.7 KB)

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